A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Hematologic Malignancies
- Registration Number
- NCT06645886
- Lead Sponsor
- Kumquat Biosciences Inc.
- Brief Summary
The goal of this clinical trial is to learn if KQB198 works to treat advanced hematologic malignancies in adults. It will also learn about the safety of KQB198. The main questions it aims to answer are:
* What is the safe dose of KQB198 by itself or in combination with other anti-cancer drugs?
* Does KQB198 alone or in combination with other anti-cancer drugs decrease the size of the tumor?
* What happens to KQB198 in the body?
Participants will:
* Take KQB198 daily, alone or in combination with another anti-cancer drug
* Visit the clinic about 8 times in the first 8 weeks, and then once every 4 weeks after that
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 122
- Adequate organ function
Part 1 and Part 2, Cohort B Participants Only:
• Ph+ CML in chronic phase who have been previously treated with at least 2 different tyrosine kinase inhibitors (TKIs) and are relapsed from or intolerant to those TKIs and ineligible for alternative therapeutic options likely to produce clinical benefit as determined by the investigator.
Part 2, Cohort A Participants Only:
• Participants with Ph+ CML in chronic phase who are on dasatinib prior to study entry and have a warning or failure to dasatinib as determined by the investigator per ELN 2020 guidelines
- CML in accelerated or blast phase
- Prior therapy with a similar mechanism of action to KQB198
- History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of study treatment or result in inability to swallow
- History of interstitial lung disease
- Cardiac abnormalities
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Monotherapy Dose Escalation KQB198 - Combo Therapy Dose Escalation KQB198 - Combo Therapy Dose Escalation Dasatinib - Combo Therapy Dose Expansion - RP2D KQB198 - Combo Therapy Dose Expansion - RP2D Dasatinib - Combo Therapy Dose Expansion - RP2D-1 KQB198 - Combo Therapy Dose Expansion - RP2D-1 Dasatinib - Monotherapy Dose Expansion - RP2D KQB198 - Monotherapy Dose Expansion - RP2D -1 KQB198 -
- Primary Outcome Measures
Name Time Method Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 1) 28 Days Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of AEs, SAEs, and DLTs, from first dose of study treatment to 28 days after last dose of study treatment.
Recommended Phase 2 Dose (RP2D) (Part 1) Up to 30 months Evaluate safety and assess number of patients with dose-limiting toxicity to determine the RP2D.
Efficacy of study treatment and optimal biologic dose, as measured by molecular response (MR) per European Leukemia Network (ELN) 2020 Guidelines (Part 2). Up to 6 Months Molecular response is the percentage of BCR-ABL fusion protein found in blood. Calculation of molecular response in Part 2 Cohort A will be the proportion of subjects that experience molecular response 4 (MR4) during the time period from 1st dose of study treatment until 6 months of study treatment. Calculation of molecular response in part 2 cohort B will be the proportion of subjects that experience molecular response 3 (MR3) during the time period from 1st dose of study treatment until 6 months of study treatment.
- Secondary Outcome Measures
Name Time Method Efficacy of Study Treatment Up to 30 months Efficacy of study treatment as measured by time to response (TTR). Response assessments will be summarized by all reported response categories at each visit.
Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 2) 28 Days After Last Dose Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of AEs, SAEs from first dose of study treatment to 28 days after last dose of study treatment.
Concentration-Time Curve (AUC) Up to 30 months Maximum Plasma Concentration (Cmax) Up to 30 months Time to Maximum Plasma Concentration (tmax) Up to 30 months
Trial Locations
- Locations (21)
Universitaetsklinikum Jena
🇩🇪Jena, Thuringia, Germany
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant Orsola
🇮🇹Bologna, Italy
Pratia Onkologia Katowice
🇵🇱Katowice, Silesian Voivodeship, Poland
University of California, San Francisco (UCSF)
🇺🇸San Francisco, California, United States
Colorado Blood Cancer Institute
🇺🇸Denver, Colorado, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Oncology Hematology Cincinnati
🇺🇸Cincinnati, Ohio, United States
Sarah Cannon Research Institute (SCRI) - Transplant and Cellular Therapy Operations
🇺🇸Nashville, Tennessee, United States
Texas Oncology Austin Central
🇺🇸Austin, Texas, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Virginia Cancer Specialists
🇺🇸Fairfax, Virginia, United States
CHRU de Tours - Hopital Bretonneau
🇫🇷Tours, Centre-Val de Loire, France
AP-HM - Hopital de la Timone
🇫🇷Marseille, France
Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
🇮🇹Roma, Lazio, Italy
Copernicus PL Sp. z o.o., Wojewodzkie Centrum Onkologii
🇵🇱Gdańsk, Pomeranian Voivodeship, Poland
Aidport Sp. z o.o.
🇵🇱Poznań, Wielkopolskie, Poland
Hospital Regional Universitario de Malaga
🇪🇸Málaga, Andalusia, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Community of Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Community of Madrid, Spain